Process Engineer (Medical Device)

SteriPack Asia Sdn Bhd (Trading as Ensera); Teluk Gong; On-site; MYR 50,000 - 73,000; Full time

Job summary

SteriPack Asia Sdn Bhd (Trading as Ensera) is seeking a Process Engineer to lead qualification activities for production equipment and tooling, and drive process improvements in the Medical Device/Pharmaceutical sector.

You will collaborate with NPI and coordinate with vendors, with a degree in mechanical/manufacturing engineering or science, 2+ years of relevant experience, ISO 13485 and GMP knowledge, and proficiency in English and Bahasa Malaysia.

Qualifications

• Degree in engineering (mechanical/manufacturing) or science.
• Minimum 2 years of relevant experience in manufacturing or medical industry.
• Knowledge of ISO 13485 and GMP is advantageous.
• Ability to lead and work with minimum supervision.
• Good written and spoken English and Bahasa Malaysia.
• Proficient with MS Office.

Responsibilities

• Manage qualification activities related to process equipment, jig, fixture and tooling used by Production.
• Lead process improvement activities for Production processes.
• Review and update routing and product structure for Production processes.
• Analyze downtime and propose improvement plans for process equipment.
• Coordinate with vendors for on-site work and equipment arrangements.
• Collaborate with NPI on process development and qualification of new equipment.
• Investigate non-conformances and lead related activities in Production.
• Lead troubleshooting and testing on process equipment as needed.
• Maintain documents/records in line with QMS requirements and prepare for audits.

Skills

Leadership

Teamwork

Analytical thinking

English proficiency

Bahasa Malaysia

Education

Engineering degree (mechanical or manufacturing) or Science

Tools

Microsoft Office

Job description

The Process Engineer is responsible for managing all qualification activities related to process equipment/ jig/ fixture/ tooling used by Production and all process improvement activities related to Production processes for the Medical Device/Pharmaceutical sector.

Key responsibilities

Review and update routing and product structure related to Production processes.

Analyze unplanned downtime for process equipment/ jig/ fixture/ tooling used by Production and propose improvement plan.

Manage co-ordination activities with vendor related to process equipment/ jig/ fixture/ tooling used by Production and to make necessary arrangements when vendor is required to work onsite.

Collaborate with NPI on process development for new projects and qualification of new process equipment/ jig/ fixture/ tooling.

Analyze and lead investigation activities initiated from non-conformances related to Production processes.

Lead troubleshooting and/ or testing activities on process equipment/ jig/ fixture/ tooling when requested by Production.

Lead Production process improvement activities and manage the required activities till they are successfully implemented and transferred to Production.

Update and maintain relevant documents / recording system related to process equipment/ jig/ fixture/ tooling, in line with current practice and QMS requirements.

Responsible in the preparation works for audit or onsite visit/ tour.

Job Requirements

Degree level education in Engineering (mechanical or manufacturing), Science or equivalent

Minimum 2 years' working experience preferably in the related field in manufacturing or medical industry

Knowledge of ISO 13485 and GMP is an advantage.

Able to lead and work in a team with minimum supervision

Good written and spoken English and Bahasa Malaysia.

Computer skill – familiar with Microsoft Office.